Multi Absorber Original, Disposable
M1173310 Multi Absorber Original, Disposable, package of 6 pcs,
GE Healthcare Finland Oy
Made in US
Rx Only
The GE Healthcare Multi Absorber Original, Disposable is a disposable product intended for use with the GE Healthcare Advanced Breathing System (later ABS), the GE Healthcare EZchange manifold, the GE Healthcare Compact Block, and the GE Healthcare Compact Block II (later Compact Block). The Multi Absorber should only be used with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane. The device is intended to be used under constant attention of qualified professional healthcare personnel.

Code Information

product number M1173310 containing lot numbers 12001 through 13031.

Recalling Firm/Manufacturer

GE Healthcare, LLC3000 N Grandview BlvdWaukesha, Wisconsin 53188-1615

Manufacturer Reasonfor Recall

GE Healthcare has recently become aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber.

FDA DeterminedCause 2

DESIGN: Device Design

Action

GE issued an Urgent Medical Device Correction letter dated September 19, 2013, to all affected customers via Fed Ex overnight mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to not use the affected product, isolate all affected product and return the attached form via fax to 800-535-7923. Once the information is received, customers would be contacted with an RMA and replacement information. If product was distributed further the notice should be forwarded to those customers. For questions customers should call 1-800-345-2700, option 2 followed by ooption 2. For foreign customers 1-800-932-0760, option 2.
For questions regarding this recall call 262-513-4122. GE issued a press release on 12/30/2013.